PF-08634404 plus chemotherapy in adults with advanced or recurrent pMMR endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares PF-08634404 in combination with chemotherapy to pembrolizumab plus chemotherapy in adults with mismatch repair-proficient (pMMR) endometrial cancer that is advanced or has recurred. Eligible participants have measurable disease or high-risk features and are eligible for non-curative treatment options. Key assessments include central testing of tumor MMR/p53 status, ECOG performance status 0-1, and adequate organ function. The study is sponsored by Pfizer with collaboration from GOG Foundation and ENGOT, and is conducted at select centers in Florida. Primary endpoints typically include progression-free survival and overall survival, with safety monitoring throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women ≥18 years of age who are confirmed not pregnant at screening.
* Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded.
* Newly diagnosed FIGO Stage III disease with measurable disease per RECIST v1.1, newly diagnosed FIGO Stage IV disease with or without measurable disease, or recurrent disease with or without measurable disease for which curative treatment with surgery and/or radiotherapy is unlikely.
* For participants with recurrent disease, prior adjuvant systemic anti-cancer therapy is allowed if relapse occurred more than 6 months after the last dose.
* Must provide tumor tissue for prospective central assessment of MMR and p53 status.
* Proficient mismatch repair (pMMR) endometrial cancer as determined by central testing.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Life expectancy of at least 12 weeks.
* Adequate organ function as defined in the protocol.

Exclusion Criteria:

* Prior systemic therapy for first-line advanced or recurrent endometrial cancer.
* Prior immunotherapy or anti-angiogenic therapy.
* Deficient mismatch repair (dMMR) endometrial cancer by central testing.
* Active or untreated central nervous system (CNS) metastases; participants with previously treated and clinically stable brain metastases may be eligible if not requiring steroids and without evidence of progression.
* Clinically significant risk of bleeding or fistula, including a history of severe bleeding disorders.
* History of another malignancy within 3 years, except for cancers with negligible risk of recurrence or death.
* History of allogeneic organ or hematopoietic stem cell transplantation; active autoimmune disease requiring systemic treatment within the past 2 years; or history of immunodeficiency
* Interstitial lung disease, pneumonitis, or clinically significant pulmonary disease
* Uncontrolled or significant cardiovascular, metabolic, renal, hepatic, or vascular disease
* Active or uncontrolled infection.
* Recent major surgery or severe trauma within protocol-defined washout periods.

Where it's running

• Jupiter Medical Center/ Anderson Family Cancer Institute
  Jupiter, Florida, United States Recruiting
• Orlando Health Ambulatory Care Center
  Orlando, Florida, United States Recruiting
• Orlando Health Cancer Institute
  Orlando, Florida, United States Recruiting
• Orlando Health Orlando Regional Medical Center
  Orlando, Florida, United States Recruiting
• Orlando Health Winnie Palmer Hospital for Women & Babies
  Orlando, Florida, United States Recruiting
• Minnesota Oncology Hematology, PA
  Coon Rapids, Minnesota, United States Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.